Senior Study Start-Up Associate

Job Summary

Driving the preparation and submission of regulatory packages for clinical trials, the full-time Senior Study Start-Up Associate will ensure compliance with global and local requirements while working remotely.

Key responsibilities

• Prepare and submit high-quality regulatory and ethics packages to ensure compliance with country regulations and ICH/GCP
• Coordinate timelines and country-specific strategies for EC/RA submissions to meet sponsor-agreed milestones
• Serve as a primary contact for study teams, sponsors, and sites to facilitate communication and accelerate regulatory approvals

Required qualifications

• Bachelor's degree preferably in (life) sciences
• 6+ years of experience in study start-up and/or regulatory affairs for clinical research, with at least 2 years in multiple countries
• Intermediate English proficiency (B1)
• Strong knowledge of clinical research processes and local regulatory regulations
• Ability to work independently and collaboratively in a matrix team environment